{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-11185", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20210924", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "LITERATURE", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20210924", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1427126", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210924", "brand_name": "DA VINCI", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "UNKNOWN", "catalog_number": "UNKNOWN", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20210924", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Nerve Damage", "Seroma", "Hematoma", "Nerve Damage", "Seroma" ] } ], "distributor_city": "", "date_report": "20210902", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "12530652", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210902", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "273353105", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENTS CANNOT BE DETERMINED OR IS UNKNOWN. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. ISI HAS ATTEMPTED TO FOLLOW-UP TO GATHER ADDITIONAL INFORMATION. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF SYSTEM AND INSTRUMENT DETAIL AS WELL AS THE EVENT/PROCEDURE DATES. WHILE PROCEDURE IMAGES WERE PROVIDED WITHIN THE ARTICLE SHOWING DEPICTING PROCEDURE TECHNIQUE, THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. UNABLE TO CONDUCT SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SITE, SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. WHILE THERE IS LIMITED INFORMATION ABOUT EACH EVENT IN ORDER TO PROVIDE A COMPLETE REPORT FOR EACH EVENT, AND THERE IS NO SPECIFIC ALLEGATION OF A DEVICE MALFUNCTION TO INVESTIGATE, THE EVENTS MEET THE CRITERIA OF A REPORTABLE ADVERSE EVENT AS IT WAS ALLEGED WITHIN THE CLINICAL ARTICLE THAT THERE WERE VARIOUS COMPLICATIONS FOR WHICH SOME WERE DESCRIBED AS REQUIRING MEDICAL INTERVENTION. AT THIS TIME, THE ROOT CAUSE OF THE ISSUES ARE UNKNOWN." }, { "mdr_text_key": "273353106", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 02-SEP-2021, DURING AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL JOURNAL REVIEW, INTUITIVE BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOTIC TRANSAXILLARY LATERAL NECK DISSECTION FOR THYROID CANCER: LEARNING EXPERIENCE FROM 500 CASES¿ FROM JANUARY 2008 TO JULY 2019 WHEREBY WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS AFTER DA VINCI SURGICAL PROCEDURES WERE NOTED: TRANSIENT HYPOCALCEMIA WAS THE MOST COMMON COMPLICATION (30.4%), FOLLOWED BY CHYLE LEAKAGE (5.2%), PERMANENT HYPOCALCEMIA (4.0%), TRANSIENT HOARSENESS (4.0%), AND SEROMA FORMATION (3.2%). FIVE (1.0%) PATIENTS HAD A PERMANENT RLN INJURY, AND THE NERVE WAS SACRIFICED DUE TO CANCER INVASION IN ONE PATIENT. THREE (0.6%) PATIENTS HAD HEMATOMA FORMATION, AND ONE OF THEM (0.2%) UNDERWENT BLEEDER LIGATION. TWO (0.4%) PATIENTS DEVELOPED HORNER¿S SYNDROME.\" THE JOURNAL ARTICLE CITED THAT, ¿FOLLOWING THE SURGERY, ALL PATIENTS RECEIVED LEVOTHYROXINE FOR THYROID-STIMULATING HORMONE (TSH) SUPPRESSION. ALL PATIENTS UNDERWENT RADIOACTIVE IODINE (RAI) ABLATION (3.7¿5.5 GBQ), POST-THERAPY WHOLE-BODY SCANS, AND DIAGNOSTIC WHOLE-BODY SCANS.¿ THE JOURNAL ARTICLE CITED THE FOLLOWING: \"THIS STUDY AIMED TO DEMONSTRATE THE TECHNICAL FEASIBILITY, COSMETIC EFFECTIVENESS, AND SAFETY OF ROBOTIC TRANSAXILLARY LATERAL NECK DISSECTION (RTLND)¿ USING ¿DA VINCI SI OR XI PLATFORMS¿ AND THAT ¿ALL OPERATIONS WERE PERFORMED SUCCESSFULLY WITHOUT OPEN CONVERSION¿. THE JOURNAL ARTICLE CITED THAT THE BACKGROUND INDICATION FOR SURGERY WAS CITED AS ¿DIFFERENTIATED THYROID CARCINOMA WITH LATERAL NECK LYMPH NODE METASTASIS¿ ISI HAS REACHED OUT TO THE JOURNAL ARTICLE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }